ROCKVILLE, Md., May 5, 2021 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: SYN), a diversified
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal (GI)
diseases in areas of high unmet need, today provided a
clinical programs update and reported financial results for the
quarter ended March 31, 2021.
Recent developments:
- Announced enrollment has commenced and three out of a total of
four cohorts have been dosed in the first Phase 1a clinical trial
of SYN-020 intestinal alkaline phosphatase ("IAP") intended to
support development of SYN-020 in multiple indications
- Announced enrollment has commenced and the first patient was
dosed in the Phase 1b/2a clinical
trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell
transplant ("HCT") recipients
- Current cash position of approximately $76.9 million
- Received $8.0 million from the
exercise of warrants
- Current cash runway provides funding into 2023 and ability to
fund Phase 1b/2a clinical trial of
SYN-004 as well as SYN-020 intestinal alkaline phosphatase ("IAP")
through proof-of-concept
Upcoming milestones, pandemic conditions permitting:
- Topline data from the Phase 1a single-ascending-dose ("SAD")
study of SYN-020 anticipated during Q3 2021
- Expect to commence second Phase 1a multiple-ascending-dose
("MAD") study of SYN-020 during Q3 2021; topline data anticipated
during Q2 2022
- Topline data readout from the first antibiotic cohort of the
SYN-004 Phase1b/2a clinical trial is expected during Q4 2021
"During the first quarter of 2021 we remained diligently focused
on advancing our portfolio of GI and microbiome-focused clinical
programs and were pleased to announce the commencement of clinical
trials for our SYN-004 and SYN-020 programs," said Steven A. Shallcross, Chief Executive Officer of
Synthetic Biologics. "Enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic hematopoietic
cell transplant (HCT) recipients is underway at the Washington University School of Medicine in
St. Louis ("Washington University") and the first patient of
the first antibiotic cohort was dosed earlier this year. We believe
SYN-004 has the potential to address an important and underserved
patient population, and may significantly improve outcomes for
allogeneic HCT recipients by preventing downstream complications
often associated with disruption of the gut microbiome by
intravenous ("IV") beta-lactam antibiotics. If enrollment proceeds
as planned, we anticipate announcing topline data from the first
antibiotic cohort during the fourth quarter of 2021, pandemic
conditions permitting."
Mr. Shallcross continued, "We were also very excited to announce
the initiation of a Phase 1a single-ascending-dose clinical trial
of our SYN-020 IAP program during the first quarter of 2021. To
date, three out of a total of four cohorts have been dosed and we
remain on track to report topline data from this study during the
third quarter of 2021, pandemic conditions permitting. A second
Phase 1a multiple-ascending-dose study is also expected to begin
enrollment during the third quarter of 2021 with topline data
expected early next year. Both studies are designed to support the
advancement of SYN-020 in multiple potential therapeutic
indications, including celiac disease, nonalcoholic fatty liver
disease ("NAFLD") and age-related metabolic and inflammatory
diseases. We are very excited about the potential for this program
to be a long-term value driver for our Company and look forward to
sharing important updates."
Mr. Shallcross concluded, "While we remain focused on the
execution of our clinical development activities, we were also able
raise net proceeds of approximately $66
million as well as $8.0
million in proceeds from the cash exercise of warrants,
significantly strengthening our balance sheet and financial
position. As a result of these activities, our current cash
position is approximately $76.9
million. Importantly, our fortified balance sheet will fully
fund our SYN-004 and SYN-020 clinical programs through
proof-of-concept clinical studies, and help accelerate our other
ongoing activities."
Clinical Development and Operational
Update
- Announced Washington University has
begun enrollment and the first patient was dosed in the first
antibiotic cohort of the Company's Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT
recipients for the prevention of acute graft-versus-host-disease
(aGVHD)
-
- The Phase 1b/2a clinical trial
comprises a single center, randomized, double-blind,
placebo-controlled clinical trial of oral SYN-004 in up to 36
evaluable adult allogeneic HCT recipients
- The goal of this clinical trial is to evaluate the safety,
tolerability and potential absorption into the systemic circulation
(if any) of oral SYN-004 administered to allogeneic HCT recipients
who receive an IV beta-lactam antibiotic to treat fever,
- Study participants will be enrolled into three sequential
cohorts and administered a different study-assigned IV beta-lactam
antibiotic. Eight participants in each cohort will receive SYN-004
and four will receive placebo
- Safety and pharmacokinetic data for each cohort will be
reviewed by an independent Data and Safety Monitoring Committee
("DSMC"), which will make a recommendation on whether to proceed to
the next IV beta-lactam antibiotic
- A topline data readout for the first antibiotic cohort is
anticipated during the fourth quarter of 2021, pandemic conditions
permitting;
- Announced enrollment has commenced and three out of a total of
four cohorts have been dosed in a Phase 1a SAD clinical trial of
SYN-020 in healthy adult volunteers
-
- The Phase 1a SAD study is designed to evaluate safety,
tolerability and pharmacokinetics of four single-ascending doses of
oral SYN-020 in healthy adult volunteers
- In all, up to 24 study participants will be enrolled into four
cohorts that will run sequentially, all of which will receive oral
SYN-020. A topline data readout is anticipated during the third
quarter of 2021, pandemic conditions permitting
- A second Phase 1a clinical trial evaluating multiple-ascending
doses of SYN-020 in healthy volunteers is expected to commence
during the third quarter of 2021. Topline data is anticipated
during the second quarter of 2022, pandemic conditions
permitting
- Both studies are intended to support the development of SYN-020
in multiple potential clinical indications including celiac
disease, NAFLD, and indications supported by the Company's
collaboration with Massachusetts General Hospital;
- Strengthened balance sheet by raising net proceeds of
$66 million from the sale of common
stock via the Company's At-The-Market ("ATM") facility and
$8.0 million resulting from the cash
exercise of a portion of Company's 2018 warrants during Q1
2021
-
- As a result of these activities, the Company has extended its
cash runway into 2023 and has the ability to fully fund its Phase
1b/2a clinical trial of SYN-004 and
planned Phase 1 SAD and MAD clinical trials of SYN-020.
Quarter Ended March 31, 2020
Financial Results
General and administrative expenses increased by 2% to
approximately $1.42 million for the
three months ended March 31, 2021,
from approximately $1.39 million for
the three months ended March 31,
2020. This increase is primarily due to higher insurance
costs, audit fees, and legal costs offset by a reduction in patent
related legal fees, consulting fees and travel expense. The charge
related to stock-based compensation expense was $82,000 for the three months ended March 31, 2021, compared to $65,000 the three months ended March 31, 2020.
Research and development expenses decreased by 32% to
approximately $1.1 million for the
three months ended March 31, 2021,
from approximately $1.6 million for
the three months ended March 31,
2020. This decrease is primarily the result of lower
indirect program costs for the three months ended March 31, 2021, including salary and related
expense reductions, a decrease in manufacturing costs for SYN-020
and market research. In addition, as a result of the global
COVID-19 pandemic, the Company's development partner (Washington University) reduced their operating
capacity during 2021 to include only essential activities as part
of their pandemic response, which delayed the start of the
Company's clinical trial, resulting in lower clinical trial
expenses for the quarter. The research and development costs
incurred during the quarter were primarily related to the Company's
Phase 1a clinical trial of SYN-020 and the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in
allogeneic HCT recipients. The Company anticipates research and
development expense to increase as ongoing clinical trials continue
to enroll patients. The charge related to stock-based compensation
expense was $19,000 for the three
months ended March 31, 2021, compared
to $18,000 related to stock-based
compensation expense for the three months ended March 31, 2020.
Other income was $347 for the
three months ended March 31, 2021,
compared to other income of $38,000
for the three months ended March 31,
2020. Other income for the three months ended March 31, 2021 and 2020 is primarily comprised of
interest income.
Cash and cash equivalents as of March 31,
2021 totaled $76.9 million, an
increase of $70.7 million from
December 31, 2020.
Conference Call
Synthetic Biologics will hold a conference call today,
Wednesday, May 5, 2021, at
4:30 p.m. (EST). The dial-in
information for the call is as follows, U.S. toll free:
1-888-347-5280 or International: +1 412-902-4280. Participants are
asked to dial in 15 minutes before the start of the call to
register. The call will also be webcast over the Internet at
https://www.webcaster4.com/Webcast/Page/1096/40931. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/40931, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal (GI)
diseases in areas of high unmet need. The Company's lead candidates
are: (1) SYN-004 (ribaxamase) which is designed to degrade certain
commonly used intravenous (IV) beta-lactam antibiotics within the
gastrointestinal (GI) tract to prevent (a) microbiome damage, (b)
Clostridioides difficile infection (CDI), (c)
overgrowth of pathogenic organisms, (d) the emergence of
antimicrobial resistance (AMR), and (e) acute
graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell
transplant (HCT) recipients, and (2) SYN-020, a recombinant oral
formulation of the enzyme intestinal alkaline phosphatase (IAP)
produced under cGMP conditions and intended to treat both local GI
and systemic diseases. For more information, please visit Synthetic
Biologics' website at www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. In
some cases forward-looking statements can be identified by
terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions, and include statements
regarding the first Phase 1a clinical trial of SYN-020 supporting
development of SYN-020 in multiple indications; topline data
from the Phase 1a single-ascending-dose ("SAD") study of SYN-020
during Q3 2021, commencing a second Phase 1a multiple
ascending-dose ("MAD") study of SYN-020 during Q3 2021 and topline
data anticipated during Q2 2022, topline data readout from the
first antibiotic cohort of the SYN-004 Phase 1b/2a clinical trial during Q4 2021, SYN-004
having the potential to address an important and underserved
patient population, and significantly improving outcomes for
allogeneic HCT recipients by preventing downstream complications
often associated with disruption of the gut microbiome by
intravenous ("IV") beta-lactam antibiotics. If enrollment proceeds
as planned, we anticipate announcing topline data from the first
antibiotic cohort during the fourth quarter of 2021, pandemic
conditions permitting, SYN-020 program being a long-term driver for
Synthetic Biologics, the financial footing allowing Synthetic
Biologics to continue its operations into 2023 as well as fully
fund its SYN-004 and SYN-020 clinical programs through
proof-of-concept clinical studies. These
forward-looking statements are based on management's expectations
and assumptions as of the date of this press release and are
subject to a number of risks and uncertainties, many of which are
difficult to predict that could cause actual results to differ
materially from current expectations and assumptions from
those set forth or implied by any forward-looking
statements. Important factors that could cause actual
results to differ materially from current expectations include,
among others, a failure to receive the necessary regulatory
approvals for commercialization of Synthetic Biologics'
therapeutics, a failure of Synthetic Biologics' clinical trials for
SYN-004 and SYN-020 to be completed on time, to provide
topline data when anticipated or to achieve desired
results and benefits, especially in light of
COVID-19, a failure of Synthetic Biologics'
clinical trials to continue enrollment as expected or receive
anticipated funding, a failure of Synthetic Biologics to
successfully develop, market or sell its products, Synthetic
Biologics' inability to maintain its material licensing agreements,
or a failure by Synthetic Biologics or its strategic partners to
successfully commercialize products and other factors described in
Synthetic Biologics' Annual Report on Form 10-K for the year ended
December 31, 2020 and its other
filings with the SEC, including subsequent periodic reports on
Forms 10-Q and 8-K. The information in this release is provided
only as of the date of this release, and Synthetic Biologics
undertakes no obligation to update any forward-looking statements
contained in this release on account of new information, future
events, or otherwise, except as required by law.
- Financial Tables Follow -
|
Synthetic
Biologics, Inc. and Subsidiaries
|
|
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
For the three
months
ended
|
|
March 31,
2021
|
|
December 31,
2020
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
76,887
|
|
$
6,227
|
Prepaid
expenses and other current assets
|
1,749
|
|
1,707
|
Property
and equipment, net
|
156
|
|
174
|
Right of
Use Asset
|
239
|
|
279
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
79,054
|
|
$
8,410
|
Liabilities and
Stockholder's Deficit
|
|
|
|
Total
liabilities
|
$
2,230
|
|
$
3,152
|
Series A
Convertible Preferred Stock
|
-
|
|
12,798
|
Synthetic Biologics,
Inc. and Subsidiaries Equity (Deficit)
|
79,598
|
|
(4,767)
|
Non-controlling
interest
|
(2,774)
|
|
(2,773)
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
79,054
|
|
$
8,410
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the three months
ended
March 31,
|
|
|
2021
|
|
2020
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
1,419
|
|
$
1,393
|
Research
and development
|
|
1,118
|
|
1,635
|
Total Operating
Costs and Expenses
|
|
2,537
|
|
3,028
|
Loss from
Operations
|
|
(2,537)
|
|
(3,028)
|
Other
Income
|
|
|
|
|
Interest
income
|
|
-
|
|
38
|
Total Other
Income
|
|
-
|
|
38
|
Net
Loss
|
|
(2,537)
|
|
(2,990)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(1)
|
|
(26)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
|
$
(2,536)
|
|
$
(2,964)
|
Series A Preferred
Stock Dividends
|
|
(24)
|
|
(62)
|
Effect of Series A
Preferred Stock price adjustment
|
|
(7,402)
|
|
-
|
Series B Preferred
Stock Dividends
|
|
(1,497)
|
|
(404)
|
Net Loss
Attributable to Common Stockholders
|
|
(11,459)
|
|
(3,430)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.13)
|
|
$
(0.20)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
|
90,807,693
|
|
17,093,920
|
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SOURCE Synthetic Biologics, Inc.